Compliance Assurance Specialist

1 week ago

Cork, Cork, Ireland beBee Careers Full time

Job Title: Compliance Specialist

Salary and Job Description:

The primary focus of this role is to ensure adherence to quality and safety standards within the laboratory. This involves supporting the day-to-day running of the QC Laboratory, completing lab investigations, human error investigations, and implementing effective CAPA (Corrective Action Preventive Action) procedures.

Responsibilities:

  • Conducting lab investigations in line with SOP requirements
  • Completing human error investigations
  • Supporting effective CAPA implementation
  • Supporting QC compliance walkdown programs
  • Reporting the outcome of the compliance walkdown program on a monthly basis
  • Supporting QC department audit readiness for internal and external inspections
  • Acting as QC representative on site Virtus (Quality Continuous Improvement) Team
  • Generating QC department PQR reports on a biannual basis in line with site PQR schedule
  • Managing compendia change processes
  • Identifying and supporting continuous improvement activities within the QC department
  • Completing CAPA, Change Plan, Audit tasks in line with site timeliness requirements
  • Supporting the preparation and review of QC department reports and metrics as required
  • Supporting QC Senior Support Analyst through Compliance Wire administration and onboarding training as needed

Safety Compliance:

This role also involves ensuring safety compliance within the laboratory. Key responsibilities include being the QC Department Safety Representative on site Green Button (safety) Team and driving the creation of a QC safety team to liaise with site EHS on lab safety improvements.

Qualifications and Skills:

  • Primary degree in analytical science or an equivalent science-based discipline
  • Minimum 3 years of experience in pharmaceutical quality control laboratory
  • Knowledge of QC regulations, including European and FDA regulations
  • Experience with QC analytical methods and procedures
  • Knowledge of QC equipment and data integrity principles

Additional Information:

AbbVie is committed to equal opportunities and diversity and inclusion. The company operates with integrity and drives innovation to transform lives and serve the community.

  • It Security And Iso Compliance Specialist

    3 days ago

    Cork, Cork, Ireland Hays Specialist Recruitment Full time

    Job Summary: Seeking a highly skilled IT Security Compliance Specialist to lead the ISO 27001 Information Security Management System of a growing design and manufacturing company.You will be the central, key member of the team responsible for developing, managing, and maintaining policies and documentation related to ISO standards.An extensive knowledge of...

  • Compliance Assurance Specialist

    5 days ago

    Cork, Cork, Ireland beBee Careers Full time

    Regulatory Compliance SpecialistThis is an exciting opportunity to join our team as a Regulatory Compliance Specialist. Your primary responsibility will be to ensure our facilities comply with all relevant regulations and standards. You will develop and implement Quality Management Systems (QMS) to guarantee documentation suites are audit-ready.

  • Quality Assurance Specialist

    3 days ago

    Cork, Cork, Ireland beBee Careers Full time

    Job Title: Quality Assurance SpecialistAs a Quality Assurance Specialist, you will play a crucial role in ensuring the quality and integrity of our products. You will be responsible for implementing and managing quality systems, providing quality oversight for business areas, conducting audits and inspections, and partnering with other areas to strengthen...

  • Quality Assurance Specialist

    1 week ago

    Cork, Cork, Ireland beBee Careers Full time

    Quality Assurance and Compliance SpecialistThis role offers an exciting opportunity to contribute to the success of a food manufacturing company by ensuring the highest standards of quality, environmental, and health and safety compliance.The Quality Assurance and Compliance Specialist will be responsible for supporting the development and implementation of...

  • Quality Assurance Specialist

    1 week ago

    Cork, Cork, Ireland beBee Careers Full time

    This is a key role within our organization that focuses on ensuring the highest standards of quality in our operations. As a Quality Assurance Specialist, you will be responsible for overseeing various aspects of our quality control processes.Key Responsibilities:Ensuring compliance with Good Manufacturing Practice (GMP) regulationsManaging batch records and...

  • Compliance Quality Assurance Specialist

    1 week ago

    Cork, Cork, Ireland beBee Careers Full time

    GMP Compliance SpecialistThis role involves performing Quality Assurance (QA) review and release of primary and secondary packaging components, as well as artwork to ensure compliance with current Good Manufacturing Practices (GMPs).You will identify deviations from accepted practices, evaluate impact and determine appropriate actions.Key...

  • Quality Assurance Specialist

    5 days ago

    Cork, Cork, Ireland beBee Careers Full time

    Overview:The position of Quality Assurance Specialist plays a crucial role in ensuring the adherence to Good Manufacturing Practice (GMP) requirements. As a key member of the team, you will be responsible for managing Quality Assurance activities, including Incoming material release, Batch release, Change control, Event management, Supplier qualification,...

  • Quality Assurance Specialist

    6 days ago

    Cork, Cork, Ireland beBee Careers Full time

    Job Title: Quality Assurance SpecialistAbout the RoleWe are seeking a highly motivated and organized Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our products and services.Key ResponsibilitiesImplement and manage quality systems to ensure compliance with regulatory...

  • Compliance and Quality Assurance Specialist

    6 days ago

    Cork, Cork, Ireland beBee Careers Full time

    As a Quality Assurance Administrator, you will be responsible for ensuring that our operations are aligned with industry best practices and regulatory requirements. This is an excellent opportunity for someone who is passionate about quality and safety.Main ResponsibilitiesDevelop and implement quality assurance procedures to ensure compliance with...

  • IT Systems Quality Assurance and Compliance Professional

    1 week ago

    Cork, Cork, Ireland beBee Careers Full time

    About the Role:We are seeking a highly motivated individual to join our team as a Business Quality Assurance Specialist, IT Systems. In this role, you will be responsible for ensuring compliance with regulatory requirements, including the development and implementation of quality systems strategy and activities. You will also provide information technology...